FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
18961–18984 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 07, 2020
AcuSee AS-P1000 System
K202119 · IYO
Weipeng (Suzhou) Medical Devices Co.,...
Radiology · 69d
Cleared Oct 07, 2020
Radiographic System Challenge X
K202293 · KPR
Sedecal., Sa.
Radiology · 55d
Cleared Oct 07, 2020
ScanX Edge
K202633 · MUH
D?rr Dental SE
Radiology · 26d
Cleared Oct 06, 2020
Pitkar DeftFix System
K200728 · KTT
S.H.Pitkar Orthotools Pvt. , Ltd.
Orthopedic · 200d
Cleared Oct 06, 2020
NuVasive® Cohere® Thoracolumbar Interbody System
K200953 · MAX
Nu Vasive, Incorporated
Orthopedic · 180d
Cleared Oct 06, 2020
R3 HA Coated Acetabular Shells
K201701 · MBL
Smith & Nephew, Inc.
Orthopedic · 106d
Cleared Oct 06, 2020
CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30,...
K202114 · GEI
Bolder Surgical, LLC
General & Plastic Surgery · 68d
Cleared Oct 06, 2020
TruForm Sievers Annuloplasty Ring
K202253 · KRH
Genesee Biomedical, Inc.
Cardiovascular · 57d
Cleared Oct 06, 2020
iSleeve Introducer Set
K202584 · DYB
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Oct 05, 2020
Neonatal Phototherapy System
K200031 · LBI
Avalon Biomedical (Shenzhen) Limited
General Hospital · 272d
Cleared Oct 05, 2020
ClearEndoclip
K200217 · PKL
Finemedix Co., Ltd.
Gastroenterology & Urology · 251d
Cleared Oct 05, 2020
MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides
K200792 · PQC
Medacta Inernational SA
Orthopedic · 193d
Cleared Oct 05, 2020
Membrane Screws and Membrane Tacks
K201561 · DZL
Neoss Limited
Dental · 117d
Cleared Oct 05, 2020
KHEIRON® Spinal Fixation System
K201659 · NKB
S.M.A.I.O
Orthopedic · 109d
Cleared Oct 05, 2020
UDE
K202292 · LLZ
Ebm Technologies, Inc.
Radiology · 54d
Cleared Oct 05, 2020
Affirm Contrast Biopsy
K202294 · IZH
Hologic, Inc.
Radiology · 53d
Cleared Oct 02, 2020
Arthrex SoftStitch
K190707 · GAT
Arthrex, Inc.
General & Plastic Surgery · 563d
Cleared Oct 02, 2020
Slow Wave DS8
K191320 · LQZ
Slow Wave, Inc.
Dental · 506d
Cleared Oct 02, 2020
SOZO Body Fluid Analyzer
K193410 · DSB
ImpediMed Limited
Gastroenterology & Urology · 298d
Cleared Oct 02, 2020
OssGuide
K200623 · NPL
Sk Bioland Co., Ltd.
Dental · 207d
Cleared Oct 02, 2020
BZF-29
K200682 · KLE
GC America, Inc.
Dental · 200d
Cleared Oct 02, 2020
Infrared Thermometer Model E127
K201161 · FLL
Bioland Technology, Ltd.
General Hospital · 155d
Cleared Oct 02, 2020
Encore System
K201238 · ORY
Siesta Medical, Inc.
Dental · 148d
Cleared Oct 02, 2020
X100 with Full Field Peripheral Blood Smear (PBS) Application
K201301 · JOY
Scopio Labs , Ltd.
Hematology · 140d